Validation engineers are an integral part of the operation and manufacturing process of any pharmaceutical, biotechnology and medical device company. Throughout their careers, they carry out crucial functions to ensure that drugs and treatments are safely and effectively produced for patients all over the world.
Validation engineer jobs are on the rise and always in demand. If you are thinking about starting out on your validation engineer career path, take some time to explore if it is the right direction for you, how to get started and the career growth opportunities that are available.
What is a validation engineer?
Validation engineers evaluate, test and maintain equipment used by companies to develop, manufacture and dispense drugs and devices. In short, they make sure that everything works how it should be by running quality tests. There are validation engineer job opportunities across the entire life sciences industry, including pharmaceutical, biotechnology, and medical devices companies.
Different types of validation roles
Validation engineer is an umbrella term for a group of engineers who specialise in different types of quality control. For example, a computerised system validation (CSV) engineer is responsible for ensuring computer systems work as they should. Other validation engineering roles include process engineers, automation engineers, and validation analysts, who focus more on scientific aspects.
What does a validation engineer do?
Validation engineers are responsible for testing equipment, computer systems, methodology and processes. Day-to-day, they create reports and adjust equipment or processes that need to be improved or repaired. To ensure that what they are testing meets standards, validation engineers carry out the following responsibilities:
- Establish validation standards
- Develop testing protocols
- Test equipment and maintain records for later analysis
- Document and report the analysis of tests
One of their most significant duties is writing protocols. This requires in-depth knowledge of the product or equipment so that they can gauge what the necessary output is and if it meets the pre-defined criteria.
What is the demand for validation engineers?
As the job role of a validation engineer requires a very niche skillset, demand for this career path will always be high. Every pharmaceutical and medical device company needs to employ skilled validation engineers across the board as every aspect of their development and manufacturing processes needs to be quality checked against regulations.
This high demand opens up many opportunities for validation engineers who choose to become contractors working on short-term projects on high hourly rates.
As a contract validation engineer, there is the option to work on remediation projects. This is a popular choice for many as opportunities are plentiful. Being contracted for a remediation project involves being sent to a company to quickly and effectively resolve a quality issue, often in manufacturing, to help them to pass health authority audits by regulatory bodies.
What qualifications and training do I need to get a validation engineer job?
Validation engineer jobs require being educated to degree level in a subject such as electrical or mechanical engineering or computer science, depending on the field of validation you wish to go into. Good mechanical understanding is also needed to be able to understand laboratory equipment and processes.
How do I get the right experience for validation engineer jobs?
The key to successfully moving into the life science industry is to gain some solid experience within a regulated industry before applying for a quality role at a pharmaceutical or medical devices company. Often, a generalist engineer will work on a project within this field and then choose to specialise and become a validation/quality engineer.
Validation engineers come from various different engineering disciplines including automation, mechanical and chemical. As long as you have a relevant educational background paired with a quality mindset, you will have all the tools you need to be successful as a validation engineer.
What are different validation engineer career paths and growth opportunities?
We have outlined the two validation engineer career paths that people typically follow to give you a taste of the growth opportunities that are available.
Candidate A’s managerial career path:
Candidate A has worked as a process validation engineer for several years. There has been a clear-cut career path for them to follow with various stages of progression, usually around four. Eventually, Candidate A progresses into a leadership position.
Candidate B’s subject matter expert career path:
Perhaps the most popular career path for validation engineers is to become a subject matter expert (SME).
Candidate B has worked as a CSV engineer for many years. Keen to use their expertise to develop their career, they work on short-term (6 month) projects, while getting paid high hourly rates for their expertise. Essentially taking a freelance position, Candidate B uses this freedom to work internationally.